MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-08 for UNK CAPIOX ARTERIAL FILTER manufactured by Terumo Corporation, Ashitaka.
[141196839]
Implanted date: device was not implanted. Explanted date: device was not explanted. 510(k): k943917. Device manufacture date - unknown due to unknown lot number. The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted. The production product code/lot number combination was not provided by the user facility, which prevented a meaningful review of the device history record. With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[141196840]
The user facility reported that the key of the tracks that comes with the capiox arterial filter presents leaks. The actual sample was changed out. There was no immediate patient impact. The procedure outcome and final patient impact was reported to be unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681834-2019-00049 |
| MDR Report Key | 8491341 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-08 |
| Date of Report | 2019-04-08 |
| Date of Event | 2019-03-13 |
| Date Mfgr Received | 2019-03-19 |
| Date Added to Maude | 2019-04-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | THERESA MUSSAW |
| Manufacturer Street | REG. NO. 2243441 2101 COTTONTAIL LN. |
| Manufacturer City | SOMERSET NJ 08873 |
| Manufacturer Country | US |
| Manufacturer Postal | 08873 |
| Manufacturer Phone | 8002837866 |
| Manufacturer G1 | TERUMO CORPORATION, ASHITAKA |
| Manufacturer Street | REG. NO. 9681834 150 MAIMAIGI-CHO |
| Manufacturer City | FUJINOMIYA CITY, SHIZUOKA 418 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 418 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK CAPIOX ARTERIAL FILTER |
| Generic Name | FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE |
| Product Code | DTM |
| Date Received | 2019-04-08 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CORPORATION, ASHITAKA |
| Manufacturer Address | 150 MAIMAIGI-CHO FUJINOMIYA CITY, SHIZUOKA 418 JA 418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-08 |